Reducing heart disease risk in 12–15-year-olds with severe obesity
Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity (MODERN)
This will try semaglutide in 12–15-year-olds with class 2–3 obesity to see if it changes weight, heart-related risk markers, body composition, and fitness over about a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT06967389 on ClinicalTrials.gov |
What this trial studies
This observational study gives semaglutide to about 50 adolescents (ages 12–15) with class 2 or 3 obesity seen at the University of Kentucky Pediatric High BMI Clinic and follows them for approximately 12 months. Participants will be titrated to a maintenance semaglutide dose and undergo baseline and ~12-month follow-up assessments including cardiac MRI or echocardiography, body composition testing, exercise/fitness testing, and blood and urine sampling. There is no randomization or placebo arm; all enrolled participants receive the drug and biologic samples will be stored de-identified indefinitely. The analysis will track how weight loss, BMI, body composition, heart structure/function, and fitness change together and whether sex or other factors influence outcomes.
Who should consider this trial
Good fit: Ideal candidates are 12–15-year-olds with class 2 or 3 obesity who are patients at the University of Kentucky Pediatric High BMI Clinic and meet clinical criteria to start semaglutide without exclusionary conditions.
Not a fit: Patients currently taking other anti-obesity or certain antihypertensive medications, with active organ disease, pregnancy, MRI incompatibility, or genetic syndromes associated with obesity are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, it could show semaglutide reduces BMI and improves heart structure, function, and fitness in severely obese adolescents, lowering future cardiovascular risk.
How similar studies have performed: Large adult trials have shown substantial weight loss with semaglutide, and emerging pediatric reports are promising though controlled pediatric outcome data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient seen at University of Kentucky Pediatric High BMI Clinic * Diagnosis of Obesity Class 2 or 3 * Meeting the clinical criteria for the medical intervention with semaglutide for weight loss Exclusion Criteria: * Any current prescribed anti-obesity medications (AOM) such as Orlistat, Phentermine, Qsymia (Phentermine/Topiramate), Liraglutide, Semaglutide, and Setmelanotide * Any current prescribed anti-hypertensive medications * Any specific end-organ acute concerns (kidney disease, liver disease, congenital disease). * Any active infections at enrollment. * Any systemic steroid use longer than 3 month use or within the last month before enrollment (not including inhaled, ophthalmic, intranasal, and topical). * Any limitations that would make exercise testing not possible. * Any congenital abnormality or genetic syndrome known to be associated with obesity * Pregnancy * Inability to receive an MRI * Personal or family history of medullary thyroid carcinoma (per product insert) * Patients with Multiple Endocrine Neoplasia syndrome type 2 (per product insert)
Where this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Margaret Murphy, RD PhD — University of Kentucky
- Study coordinator: Margaret Murphy, RD PhD
- Email: maggie.murphy@uky.edu
- Phone: 859-323-2969
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.